EUCTR2015-002756-27-GB进行中（未招募）1 期
A multicenter, open-label, single-arm study to evaluate the pharmacokinetics, efficacy, and safety of brivaracetam in neonates with repeated electroencephalographic seizures - PETITE
CB Biopharma SPR0 个研究点目标入组 42 人开始时间: 2017年3月27日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 42
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •- Confirmation on video-electroencephalography (VEEG) of >= 2 minutes of cumulative electroencephalographic neonatal seizures (ENS), or >=3 identifiable ENS prior to entering the Evaluation Period, despite receiving previous antiepileptic drug treatment for the treatment of electroencephalographic seizures. The occurrence of ENS during an up to 1-hour period must be confirmed either by the local or central VEEG reader prior to drug administration. Preferably, the central VEEG reader should confirm the required ENS.
- •- Subject is male or female and must be at least 34 weeks of corrected gestational age (CGA). In Addition, term neonates up to 27 days of postnatal age (PNA) and preterm neonates up to 40 weeks of postmenstrual age (PMA) and 27 days of PNA can be enrolled
- •- Subject weighs at least 2.3 kg at the time of enrollment
- •- Subjects with or without concomitant hypothermia treatment
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 42
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range 0
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •- Subject receiving antiepileptic drug (AED) treatment other than phenobarbital, midazolam, phenytoin, levetiracetam (=60 mg/kg/day), or lidocaine for the treatment of seizures prior to or at the time of enrollment (Confirmatory Cohorts only)
- •- Subject with seizures responding to previous AED treatment immediately prior to BRV treatment, pyridoxine treatment, or correction of metabolic disturbances (hypoglycemia, hypomagnesemia, or hypocalcemia)
- •- Subject requires extra corporeal membrane oxygenation
- •- Subject has seizures related to prenatal maternal drug use or drug withdrawal
- •- Subject has known severe disturbance of hemostasis, as assessed by the Investigator
- •- Subject has a poor prognosis for survival, as judged by the Investigator
- •- Subject has 2x upper limit of normal (ULN) of any of the following: aspartate aminotransferase AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP), with the following exception:
- •For subjects with perinatal asphyxia, elevation of AST, ALT or ALP <5x ULN is acceptable, if initial and peak elevation of liver function tests (LFTs) occurs within 5 days after birth, and the time course of LFT elevation is compatible with hepatic injury due to perinatal asphyxia.
- •The determination of ULN will be based on the subject's gestational age (GA) and the site's normal range values for the respective GA
- •- Subject has direct (conjugated) bilirubin levels >2 mg/dL
- •- Subject requiring or expected to require phototherapy or exchange transfusion due to elevated bilirubin
- •- Subject with rapidly increasing bilirubin that may preclude the subject from inclusion in the study at the discretion of the Investigator
研究者
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